Guidance for industry SUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation.

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Bibliographic Details
Corporate Author: Center for Drug Evaluation and Research (U.S.)
Format: Government Document Electronic eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]
Physical Description:
1 electronic resource (ii, 36, 6, 6 pages)
Subjects:
Solid dosage forms -- United States -- Testing.
Drugs -- Therapeutic equivalency -- Documentation -- United States.
Online Access:https://purl.fdlp.gov/GPO/LPS121122
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Holdings details from CMU Gov Pub Electronic C502
Copy 1 CMU Gov Pub Electronic HE 20.4702:SCA 4/2 Online

Internet

https://purl.fdlp.gov/GPO/LPS121122
Full text

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